MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML HEPARIN 10 UNIT; HEPARIN, VASCULAR ACCESS FLUSH

Catalog Number 306413

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

Material no: 306413 batch no: unknown.It was reported that before use of the syringe 3ml heparin 10 unit the syringe has incorrect data related to latex in the fda gudid database.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.The following information was provided by the initial reporter: event description per attached email states, "the posiflush syringe has incorrect data related to latex.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.

Event Description

Material no: 306413; batch no: unknown.It was reported that before use of the syringe 3ml heparin 10 unit the syringe has incorrect data related to latex in the fda gudid database.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.The following information was provided by the initial reporter: event description per attached email states, "the posiflush syringe has incorrect data related to latex.The label for this product states "this product is not made with natural rubber latex or preservatives".The data in the gudid suggests otherwise.

Manufacturer Narrative

H.6.Investigation: one photo was provided for evaluation.It shows the shelf box drawing.Highlighting: this product is not made with natural rubber latex or preservatives.This packaging is in accordance with our drawing and specifications.This complaint has been reported to our posiflush platform.A device history record review could not be completed as no batch number was provided.H3 other text : see h.10.

• Brand Name: SYRINGE 3ML HEPARIN 10 UNIT
• Type of Device: HEPARIN, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9194434
• MDR Text Key: 194363234
• Report Number: 1911916-2019-01093
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064138
• UDI-Public: 30382903064138
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306413
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other